Cardinal Health Fluoride Anticavity

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 2.43mg in 1g
Labeler: Cardinal Health
NDC code: 63517-016

Medically reviewed by Drugs.com. Last updated on Dec 20, 2023.

Drug Facts:

NDC (63517-016-96)

Active Ingredient:

Sodium fluoride - 0.243% w/w

Purpose

Anticavity toothpaste

Uses:

Aids in the prevention of dental decay

Warnings:

If you accidentally swallow more than used for brushing ,seek medical help or contact a Poison Control Center right away.

Keep out of the reach of children under 6 years of age.

Directions:

Adults and Children 2 years of age and older: Brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist or physician.
Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
Chlidren under 2 years of age: Consult a dentist or physician.

Inactive ingredients:

Cellulose Gum, Flavor, Disodium Phosphate, and FD&C Blue No. 1, Glycerin, Hydrated Silica, PEG 6, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water

Principal Display Panel - .85oz 144 count Box

anticavity toothpaste with fluoride

ADA accepted

Principal Display Panel .85 oz -Tube

anticavity toothpaste with fluoride

Cardinal Health net wt. 0.85oz ( 24g)

CARDINAL HEALTH FLUORIDE ANTICAVITY
fluoride anticavity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63517-016
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	2.43 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL
WATER
HYDRATED SILICA
GLYCERIN
SODIUM LAURYL SULFATE
PEG-6 STEARATE
CARBOXYMETHYLCELLULOSE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SACCHARIN SODIUM
TITANIUM DIOXIDE
FD&C BLUE NO. 1

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:63517-016-96	144 TUBE in 1 CASE
1		24 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/09/2013

Labeler - Cardinal Health (961027315)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(63517-016)

Document Id: 1ab1ab30-2c3b-478f-9c9a-b28b058828ad

Set id: cd5570d9-83b6-441b-a0c1-43d95b6b61f4

Version: 2

Effective Time: 20191230

Cardinal Health

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer